Exercise Effects on Cardiometabolic Health and Sestrin-2 in Hypertensive Obese Women

NCT07370363 | Not Yet Recruiting

• 1 other identifier: KayseriCHsestrin2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a chronic and complex disease characterized by excessive fat accumulation that adversely affects health and quality of life. It is commonly accompanied by low-grade chronic systemic inflammation, which contributes to the development of insulin resistance, type 2 diabetes, dyslipidemia, hypertension, and cardiovascular diseases. Hypertension is highly prevalent among individuals with obesity, and excess body weight is a major contributor to elevated blood pressure and related cardiometabolic risk. Regular aerobic exercise is a cornerstone of non-pharmacological management for both obesity and hypertension and has been shown to reduce chronic inflammation by downregulating pro-inflammatory pathways and upregulating anti-inflammatory mechanisms. Sestrin-2, a stress-responsive protein encoded by the SESN2 gene, has been proposed as an important regulator of metabolic homeostasis and inflammation through activation of the AMPK pathway and inhibition of NF-κB signaling. However, evidence regarding the effects of different exercise modalities on circulating Sestrin-2 levels in hypertensive obese individuals remains limited. This prospective, randomized controlled trial aims to compare the effects of two different aerobic exercise protocols on serum Sestrin-2 levels, inflammatory status, and cardiometabolic parameters in hypertensive obese women. Cardiopulmonary exercise testing will be used to comprehensively assess cardiorespiratory fitness and physiological responses to exercise. The results of this study are expected to contribute to a better understanding of exercise-induced anti-inflammatory mechanisms and to support the development of safe, effective, and applicable exercise prescriptions for hypertensive obese women.

Conditions

Hypertension; Obesity

Keywords

Hypertension; obesity; VO2max; Cardiopulmonary Exercise Testing; Sestrin-2; Aerobic Exercise

Outcome Measures

Primary Outcomes (2)

• Serum Sestrin-2 Level

  Serum Sestrin-2 levels will be measured using enzyme-linked immunosorbent assay (ELISA). Blood samples will be collected 48 hours before the start of the 8-week exercise program and 48 hours after completion of the intervention in order to avoid the acute effects of exercise. The primary outcome is the change in Sestrin-2 levels from baseline to post-intervention.

  Baseline and end of 8-week intervention

• Maximal Oxygen Consumption (VO2max)

  VO2max will be assessed using cardiopulmonary exercise testing (CPET) according to standardized protocols. Measurements will be performed before the start of the exercise program and after completion of the 8-week intervention. The change in VO2max from baseline to post-intervention will be analyzed.

  Baseline and end of 8-week intervention

Secondary Outcomes (9)

• Lipid Profile

  Baseline and end of 8-week intervention

• Insulin Resistance

  Baseline and end of 8-week intervention

• Functional Capacity

  Baseline and end of 8-week intervention

• Blood Pressure

  Baseline and end of 8-week intervention

• Change in body weight

  Baseline and Week 8

Study Arms (2)

Moderate-Intensity Continuous Exercise

EXPERIMENTAL

Participants perform supervised moderate-intensity continuous aerobic exercise at a prescribed intensity and frequency.

Behavioral: Moderate-Intensity Continuous Exercise

Brisk Interval Exercise

EXPERIMENTAL

Participants perform supervised interval aerobic exercise consisting of alternating bouts of higher and moderate intensity.

Behavioral: Brisk Interval Exercise

Interventions

Brisk Interval Exercise BEHAVIORAL

Supervised interval aerobic exercise consisting of alternating bouts of higher and moderate intensity performed throughout the intervention period.

Brisk Interval Exercise

Moderate-Intensity Continuous Exercise BEHAVIORAL

Supervised moderate-intensity continuous aerobic exercise performed at a prescribed intensity and frequency for the duration of the intervention period.

Moderate-Intensity Continuous Exercise

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged between 30 and 65 years
• Body mass index between 30.0 and \<40.0 kg/m² (Class I and Class II obesity)
• Diagnosis of hypertension according to the 2018 European Society of Hypertension/European Society of Cardiology (ESH/ESC) guidelines
• Sedentary lifestyle, defined as total weekly exercise duration of less than 60 minutes
• Medically eligible for exercise participation, with approval from a Physical Medicine and Rehabilitation specialist and an Internal Medicine specialist
• Willingness to participate in the study and provision of written informed consent

You may not qualify if:

• Neuromuscular disorders, uncontrolled psychiatric diseases, or cognitive impairment limiting exercise participation
• Congestive heart failure, unstable angina, or acute cardiac conditions including acute myocardial infarction, acute endocarditis, myocarditis, or pericarditis
• Presence of uncontrolled systemic diseases, including:
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• Chronic liver failure
• Chronic kidney disease or patients receiving dialysis
• Chronic obstructive pulmonary disease or asthma
• History or presence of malignancy
• Acute infection at the time of enrollment
• Acute peripheral vascular disease
• Symptomatic severe aortic stenosis
• Acute pulmonary embolism or pulmonary infarction
• Use of systemic corticosteroids or immunosuppressive medications
• Inability to comply with the study protocol or lack of cooperation

Sponsors & Collaborators

• Havva Talay Çalış: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kayseri, Turkey (Türkiye)

Location

Related Publications (2)

• Lee JH, Budanov AV, Karin M. Sestrins orchestrate cellular metabolism to attenuate aging. Cell Metabolism. 2013;18(6):792-801.

  BACKGROUND

• Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. European Heart Journal. 2018;39(33):3021-3104.

  BACKGROUND

MeSH Terms

Conditions

Obesity; Hypertension

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Rukiye AKAY, MD

CONTACT

+905392333789; rukiye.akay@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)